safety, pharmacokinetics, and pharmacodynamics of mk-6325 in hepatitis c virus (hcv) infections (mk-6325-003)

Conditions: Hepatitis C

Summary: this is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of mk-6325 in hcv-infected participants. part i of the study will be for genotype (gt) 1 hcv-infected participants who will be randomized to receive either mk-6325 or placebo. if the drug is shown to be safe and efficacious in part i, part ii will enroll gt 3 hcv-infected participants who will be randomized to receive either mk-6325 or placebo.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18 to ≤37 kg/m\^2. * stable health * no clinically significant abnormality on electrocardiogram (ecg) * clinical diagnosis of chronic hcv infection (g1 or g3) for at least 6 months and detectable hcv rna in peripheral blood. exclusion criteria: * pregnancy or intention to become pregnant or father a child during the course of the study. * history of stroke, chronic seizures, major neurological disorder, or uncontrolled clinically significant psychiatric disorder (for example, depression). * estimated creatinine clearance of ≤70 ml/min. * history of clinically significant endocrine, gastrointestinal (except hcv infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases whose current condition is considered clinically unstable. * history of neoplastic disease other than adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix ≥10 years prior to the prestudy (screening) visit with no evidence of recurrence of likelihood of recurrence. * positive hepatitis b surface antigen at the pre-study (screening) visit. * history of documented hiv infection or positive hiv serology at the pre-study (screening) visit. * regular consumption of excessive amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml/10 ounces\], wine \[125 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) per day. * excessive consumption, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) or coffee, tea, cola, or other caffeinated beverages per day. * major surgery, or donation or loss of 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit. * history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. * regular use of (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 months. exception: marijuana use is permitted at the discretion of the investigator and provided the participant can refrain from its use during the study. * evidence or history of chronic hepatitis not caused by hcv including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, autoimmune hepatitis. note: participants with history of acute non-hcv-related hepatitis, which resolved \>6 months before study can be enrolled. * previous treatment with other hcv protease inhibitors ≤3 months prior to the first dose of study drug. * previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of mk-6325 in the study. * clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (metavir score ≥3) from prior liver biopsy. note: liver biopsy is not required for entry into the study.